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The agency cites deviations from CGMPs for the manufacture of APIs at the company's Gujarat, India plant.
FDA issued a warning letter to Cadila Pharmaceuticals Limited (Gujarat, India) on Oct. 15, 2014 for deviations from CGMPs for the manufacture of APIs. FDA citations included failure to implement corrective actions, failure to manufacture APIs in compliance with CGMPs, and failure to manage data effectively.
An FDA inspector specifically pointed out failures by the company to investigate customer complaints of unpleasant odors in batches of product and to implement corrective actions. In the warning letter, FDA stated the company did not provide data to support their conclusion and closed out their investigation before a corrective active was implemented. FDA stated that the company received further complaints after their initial investigation.
FDA also cited the company’s quality unit for not ensuring that APIs manufactured are in compliance with CGMP and meet established specifications for quality and purity. The warning letter states, “Your firm released (b)(4) API batch (b)(4) with an unknown peak present in the residual solvents chromatogram. Although this unknown peak was not a part of your historical impurity data, neither the analyst nor the supervisor apparently noticed or evaluated this unknown peak during their reviews.
“Subsequently, a customer complaint was received for this batch, and your investigation identified the unknown peak as (b)(4). Your firm found that this peak was a result of a contamination that occurred during your manufacturing process.”
The company was also cited for not having proper controls in place to prevent the unauthorized manipulation of electronic raw data. FDA stated in the letter, “the inspection found that the audit trail feature for your gas chromatography (GC) instruments was not used until October 2013, even though your 2009 GC software validation included a satisfactory evaluation of the audit trail capability. There is no assurance that you maintain complete electronic raw data for the (b)(4) GC instruments, the Malvern particle size analyzer, and the ultraviolet (UV) spectrophotometer. Our inspection found that these instruments were connected to stand-alone computers that stored the data and that the data could be deleted. Prior to our inspection, your firm failed to have a back-up system for the data generated by one of the (b)(4) Fourier transform infrared spectrometers, the polarimeter, the UV spectrophotometer and the Malvern particle size analyzer.”
The letter also mentions the lack of testing of stability samples at required intervals, including a backlog of samples. According to FDA, the company was cited for the same infraction in 2012 and has failed to properly address the situation.